The Recall Desk
ModerateFDA (Devices)·Z-1556-2021·Announced 2021-05-19

Medical Action Industries Recalls Midline Insertion Kits Due to Package Integrity

Medical Action Industries is recalling 110 cases of Midline Insertion Kits because a component may have a package integrity breach.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences, aligning with the Moderate severity level for minor labeling or packaging issues without reported injuries.

Plain-English summary

Medical Action Industries, Inc. is recalling 110 cases of Midline Insertion Kits (Part Number 77981B). The recall is due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

The affected kits were distributed nationwide to Ohio, Oregon, Florida, and California. The recall includes specific lot numbers with expiration dates ranging from July 2021 to April 2022.

Consumers and healthcare facilities should check their inventory for the specific part number and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
Manufacturer
Medical Action Industries, Inc. 306
Category
Medical Device — Surgical Kits
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Kit Number: 77981B
  • UDI (GTIN): 20809160284053
  • Lot Number: 0000281502 (Expiration Date: 04/08/2022)
  • 0000282039 (Expiration Date: 04/08/2022)
  • 0000274390 (Expiration Date: 07/09/2021)
  • and 0000279101 (Expiration Date: 11/13/2021)

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Medical Action Industries, Inc. 306 under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Medical Action Industries, Inc. 306

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Same hazard · package integrity

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